Comparing the Effectiveness of Nonsurgical Treatments for Lumbar Spinal Stenosis in Reducing Pain and Increasing Walking Ability

This project has results

Abstracts

Public Abstract

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What was the research about?

Lumbar spinal stenosis is a health problem that is common in older adults. In people with this health problem, the space between vertebrae in the spine narrows. This narrowing can cause pressure on the nerves in the lower back, which can cause pain and can make it difficult to walk. Doctors often recommend spine surgery to improve symptoms. But many people prefer to avoid back surgery if they can.

In this study, the research team wanted to see if treatments that don’t involve surgery helped improve patients’ symptoms. The team compared three types of treatment. These treatments were pain medicine, group exercise classes, and chiropractic plus physical therapy.

What were the results?

Two months after the study started, patients in all three groups saw improvement in pain and physical function. Compared with patients who exercised or used pain medicine, those who had chiropractic and physical therapy had more improvement in pain. Patients who exercised and patients who used pain medicine showed the same amount of improvement in pain. All three groups had the same improvement in walking ability.
All three groups showed the same improvement in pain and walking ability six months after the study started.
Patients who exercised had more daily activity compared to patients who took medicine two months after the study began. However, these improvements didn’t last when the team looked at daily activity again at six months.

Who was in the study?

The study included 259 patients with lumbar spinal stenosis that led to difficulty walking. To be in the study, patients had to be age 60 or older, able to walk at least 50 feet without help, and able to do light exercise. Patients lived in Pittsburgh, Pennsylvania. About the same number of men and women were in the study. In addition, 77 percent of patients were white, 22 percent were black, and 1 percent were other races. The average age was 72. About half of patients had a college degree.

What did the research team do?

The team assigned patients to one of three groups by chance. Each group received treatment for six weeks. One group received pain medicine and met with a doctor three times. The doctor prescribed more pain medicine if needed. If the medicine didn’t help enough, the doctor prescribed steroid injections. Patients in the second group took two group exercise classes per week at local senior centers. In the third group, patients got two chiropractic and physical therapy treatments per week at a health clinic. The research team gave all the patients armbands that measured their daily activity.

Doctors, senior center directors, and patients with experience with lumbar spinal stenosis gave input on the study design.

What were the limits of the study?

Some patients took off the armband used to measure daily activity because it wasn’t comfortable. The results may have been different if all patients wore the armband all the time. Also, the walking test only tested patients’ ability to walk on flat surfaces. For patients who need to walk up hills or stairs, the results may not be helpful.

Future studies could test combinations of the treatments used in this study. Studies could also test the effect of using these treatments for a longer time.

How can people use the results?

Doctors can use the results from this study to help patients decide on nonsurgical treatment options for lumbar spinal stenosis.

Professional Abstract

Objective

To compare the effectiveness of prescription medicine, nonspecific group exercise classes, and chiropractic and physical therapy combined with rehabilitative exercises for reducing pain and increasing walking ability in patients with lumbar spinal stenosis (LSS)

Study Design

Design Elements	Description
Design	Randomized controlled trial
Population	259 adults ages 60 and older who had difficulty walking due to LSS
Interventions/ Comparators	Prescription pain and antidepressant medicines; epidural steroid injections for nonresponders Community-based group exercise classes Clinic-based chiropractic and physical therapy combined with rehabilitative exercises designed to treat LSS
Outcomes	Primary: self-reported level of pain and physical function, test of walking ability Secondary: daily physical activity
Timeframe	6-month follow-up for primary outcomes

The research team compared three nonsurgical treatments for LSS to see if the treatments reduced pain and increased walking ability in patients with LSS.

To be eligible for the trial, participants had to be able to walk at least 50 feet without assistive devices and able to engage in light exercise, like back stretches or riding a stationary bike for 5 to 10 minutes. In this study, 77% of patients were white, 22% were black, and 1% were other races. The average patient age was 72, and about half of patients had a college degree. The study took place in Pittsburgh, Pennsylvania.

The research team randomized patients to one of three groups. Patients in the first group received prescription medicine as needed, including pain medication and antidepressants. For progressive pain, patients received epidural steroid injections. Patients in this group met with a physician three times. The physician reviewed the patients’ current medicines for LSS and modified the medicine regimen as needed for pain. In the second group, patients attended two group exercise classes per week led by fitness instructors at a local senior community center. Exercises were for general fitness. Two times each week, patients in the third group had chiropractic and physical therapy combined with rehabilitative exercises designed to treat LSS. The interventions in each group lasted for six weeks.

Patients with LSS, community senior centers directors, and doctors gave input on the study design to the research team.

Results

All three groups showed improvement in mean scores for pain and physical function at two months. Participants who received chiropractic and physical therapy had a significantly greater improvement compared with those who did group exercise (-2.4 points; 95% confidence interval [CI], -4.2, -0.6) or received prescription medicine (-2.1 points; 95% CI, -3.9, -0.4). Patients in all three groups showed the same level of improvement in walking ability.
At six months, there were no significant differences between groups in improvement in pain and physical-function scores. Although all three groups showed improvement in walking ability, there were no statistically significant differences between the three groups.
Compared to those who received prescription medicine, patients who took group exercise classes had statistically significantly greater improvement in daily physical activity after two months. However, compared to baseline, none of the groups showed improvement in physical activity after six months.

Limitations

Some patients took off the armband used to measure daily activity because it was uncomfortable, resulting in missing data at follow-up. Daily activity results may have been different if all patients had used the armband. The walking test only assessed patient ability to walk on flat surfaces; results may not be generalizable to more challenging mobility tasks.

Conclusions and Relevance

In the short term, chiropractic and physical therapy patients had the greatest improvements in pain compared with patients in the exercise and prescription medicine groups. At six months, all three groups showed similar improvements in pain, physical function, and walking ability. For patients who choose not to have surgery, all three interventions may improve their ability to manage their LSS.

Future Research Needs

Further research could examine the effectiveness of using these treatments for longer periods or test different combinations of these interventions.

This project's final research report is expected to be available by January 2019.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.

In response to peer review, the PI made changes including

Clarifying what they meant by following an “intention-to-treat principle” in designing analyses. The researchers explained that they included all participants who were randomized in the analysis, using statistical approaches to account for missing follow-up data from participants who had dropped out of the study.
Modifying the Discussion and Conclusion sections of the report to reflect the considerable heterogeneity of treatment response in the three treatment groups. The reviewers pointed out that, although some patients in each study arm improved considerably, the variability in response was large enough to make the overall differences between study arms very small.
Adding a discussion in the Limitations section about the potential for bias in the results because of differences in motivation and attention by type of intervention. These additions responded to reviewer concerns that participants who stayed in the group-exercise arm were likely to be more highly motivated than those who dropped out, and that greater personal attention in the manual therapy/individualized exercise arm could produce greater short-term improvements in self-reported pain and functioning.
Adding a discussion weighing the potential trade-offs of clinical results versus the investment of time and cost of each intervention.

Conflict of Interest Disclosures

View the COI disclosure form.

Journal Articles

JAMA Network Open

Comparative Clinical Effectiveness of Nonsurgical Treatment Methods in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial

The Spine Journal

Individuals with lumbar spinal stenosis seek education and care focused on self-management - results of focus groups among participants enrolled in a randomized controlled trial

The Spine Journal

The patient's experience with non-surgical treatment for lumbar spinal stenosis: a qualitative study

Chiropractic & Manual Therapies

Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial

Project Details

Principal Investigator

Michael J. Schneider, DC, PhD

Project Status

Completed; PCORI Public and Professional Abstracts Posted

Project Title

A Comparison of Non-Surgical Treatment Methods for Patients with Lumbar Spinal Stenosis

Board Approval Date

December 2012

Project End Date

April 2018

Organization

University of Pittsburgh

Year Awarded

2012

State

Pennsylvania

Year Completed

2018

Project Type

Research Project

Funding Announcement

Assessment of Prevention, Diagnosis, and Treatment Options

Conditions

Muscular and Skeletal Disorders

Spinal Stenosis/Degenerative Lumbar Disorder

Multiple/Comorbid Chronic Conditions

Cardiovascular Diseases

Cardiovascular Diseases - Other

Functional Limitations and Disabilities

Ambulatory Difficulty

Independent Living Difficulty

Neurological Disorders

Chronic Pain

Nutritional and Metabolic Disorders

Diabetes

Obesity

Project Budget

$1,826,997

Study Registration Information

HSRP20142228

NCT01943435

Page Last Updated:

January 8, 2019